{"schemaVersion":"jobsearcher.job.v1","id":"b93e51963e9562a975b97d6a","url":"https://jobsearcher.com/jobs/b93e51963e9562a975b97d6a","canonicalUrl":"https://jobsearcher.com/jobs/b93e51963e9562a975b97d6a","title":"Operational Excellence Engineer","description":"PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.\n\nSUMMARY:\nThe Operational Excellence Engineer serves as the site's certified Lean Six Sigma Black Belt, leading complex, data-driven improvement projects that deliver measurable gains in yield, throughput, quality, cost, and service across OTC pharmaceutical manufacturing and packaging operations. Operating as a senior individual contributor within Operational Excellence, this role leads cross-functional DMAIC and Lean initiatives, applies advanced statistical analysis to solve chronic and high-impact problems, and builds continuous improvement capability by coaching Green Belts, Yellow Belts, and frontline teams. The role also drives digital and data-enabled improvement, partnering with Technical Services and IT to define requirements, and applying GAMP 5 and FDA Computer Software Assurance principles to ensure systems and analytical tools used in GxP decision-making are appropriately validated. All improvements are executed in a cGMP-compliant manner, with changes to validated processes, systems, equipment, and documentation routed through Change Control and approved by Quality Assurance.\n\nWork Schedule: Monday - Friday\nStarting Salary: $91,000\n\nJOB QUALIFICATIONS:\n\nBachelor’s degree in engineering (Industrial, Chemical, Mechanical, Pharmaceutical), Life Sciences, Statistics, or a related technical discipline required; advanced degree preferred\nCertified Lean Six Sigma Black Belt from a recognized body (ASQ, IASSC, or accredited corporate program) required; Master Black Belt certification or candidacy preferred\nMinimum 5–8 years of progressive experience in manufacturing, engineering, or operational excellence, including at least 3 years leading formal Lean Six Sigma projects\nExperience in OTC pharmaceutical, nutraceutical, food, or other FDA-regulated manufacturing strongly preferred; familiarity with solid dose, liquids, creams/ointments, or packaging operations preferred\nStrong working knowledge of FDA regulations and cGMP guidelines, including 21 CFR Parts 210/211 and OTC monograph requirements\nDemonstrated mastery of DMAIC, Lean tools (VSM, 5S, SMED, TPM, standard work, kanban, kaizen), and change management methodology\nAdvanced proficiency in statistical analysis and software such as Minitab, JMP, or equivalent; capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and SPC\nWorking knowledge of OEE, capacity modeling, line balancing, and process cycle efficiency\nWorking knowledge of change control, deviation/CAPA, validation, and risk assessment processes as they apply to process improvement\nExperience extracting and analyzing data from ERP, MES, LIMS, and historian systems; proficiency with Excel and data visualization tools such as Power BI or Tableau preferred\nWorking knowledge of computer system validation principles, including ISPE GAMP 5 software categorization, FDA Computer Software Assurance (CSA) risk-based methodology, 21 CFR Part 11, and ALCOA+ data integrity expectations\nExperience defining user requirements, executing IQ/OQ/PQ or UAT test scripts, and supporting validation deliverables for systems or digital tools supporting manufacturing operations\nFamiliarity with electronic batch records, automated data capture, and digital manufacturing/Industry 4.0 concepts preferred\nProven ability to lead cross-functional teams without direct authority, influence at all organizational levels, and manage multiple concurrent projects\nExcellent written and verbal communication, facilitation, and executive presentation skills\nStrong financial acumen, including the ability to build and validate benefit cases with Finance\n\nPOSITION RESPONSIBILITIES:\n\nProject Leadership & Execution\n\nLead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefits\nApply the DMAIC methodology rigorously: define problem and scope, validate measurement systems, analyze root cause with statistical evidence, pilot and implement solutions, and establish sustainable controls\nPartner with site and functional leadership to identify, scope, prioritize, and charter improvement opportunities aligned to business objectives\nManage project scope, timeline, resources, and risks; escalate barriers and report status to the Vice President, Operational Excellence and site leadership\nQuantify and validate project benefits with Finance, tracking hard savings, cost avoidance, and capacity gains through realization\n\nAnalytics & Problem Solving\n\nPerform advanced statistical analysis including capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and control charting to drive fact-based decisions\nDesign and deploy statistical process control for critical process parameters and quality attributes, establishing limits, monitoring plans, and reaction rules\nLead structured root cause investigations for chronic yield loss, downtime, rework, scrap, right-first-time failures, and repeat deviations\nBuild and maintain operational dashboards and metrics — OEE, throughput, yield, RFT, changeover time, cost per unit — to expose performance gaps and improvement opportunities\n\nLean Deployment & Operating System\n\nFacilitate value stream mapping, kaizen events, and rapid improvement workshops across manufacturing, packaging, warehouse, and laboratory value streams\nDeploy Lean tools including 5S, standard work, SMED/changeover reduction, TPM, visual management, and material flow optimization\nSupport development and sustainment of the site's daily management system, tiered accountability meetings, and problem-solving routines\nDrive waste elimination and cycle time reduction while protecting product quality, compliance, and patient safety\n\nComputer Systems, Data & Digital Improvement\n\nIdentify, scope, and lead improvement projects that leverage computer systems and digital tools to eliminate manual processes, reduce transcription error, and improve data availability across operations\nServe as business process owner or requirements author for system enhancements, configuration changes, reports, and dashboards supporting Operational Excellence, partnering with Technical Services and IT for technical delivery\nDefine user and functional requirements, build traceability to process needs, and participate in design reviews for system changes affecting operational processes\nApply a GAMP 5 and FDA CSA risk-based approach to determine the appropriate validation rigor for system changes, distinguishing between high-risk GxP functionality requiring scripted testing and low-risk functionality suitable for unscripted or exploratory testing\nAuthor and execute test cases including user acceptance testing, and support IQ/OQ/PQ execution for systems and digital tools introduced through improvement projects, submitting deliverables for independent Quality review and approval\nEnsure data integrity and ALCOA+ principles are designed into improved processes, including audit trail adequacy, electronic signature use, user access controls, and record retention\nValidate spreadsheets, statistical models, and analytical tools used for GxP decision-making in accordance with site procedures and GAMP 5 Category classification\nAssess the validation and data integrity impact of process changes on interfaced systems such as ERP, MES, LIMS, historian, and quality systems\nPartner with Technical Services on periodic review, change control, and system lifecycle activities where operational process changes are involved\n\nQuality & Regulatory Compliance\n\nEnsure all improvements affecting validated processes, equipment, utilities, materials, or documentation are executed through Change Control with Quality Assurance review and approval\nAssess regulatory, validation, and product quality impact of proposed changes in partnership with Quality, Regulatory Affairs, and Technical Services\nSupport deviation investigations and CAPA effectiveness through structured problem-solving methodology and statistical evidence\nAuthor and revise SOPs, batch record steps, and work instructions resulting from improvement initiatives, routing through the document control process\nSupport regulatory inspections and customer audits by providing process data, trending, and improvement documentation as requested\n\nCapability Building & Coaching\n\nTrain, coach, and mentor Green Belts, Yellow Belts, supervisors, and frontline teams in Lean Six Sigma tools and structured problem solving\nServe as project sponsor or technical advisor for Green Belt projects, reviewing methodology rigor and validating results\nDevelop and deliver training curriculum supporting the enterprise skills matrix and career pathing framework\nChampion a continuous improvement culture by recognizing contributions, sharing best practices, and standardizing successful solutions across PLD plants\n\nCross-Plant Standardization\n\nReplicate proven improvements across sites to build consistency in process, standard work, and performance expectations\nParticipate in enterprise Operational Excellence forums to share learnings and align on common methodology, metrics, and definitions\n\nPHYSICAL REQUIREMENTS:\n\nOccasionally lift objects weighing up to 25 pounds\nClimb stairs when needed\nStand and walk on the manufacturing floor for extended periods during observations, kaizen events, and time studies\nSit for long periods of time\nOccasionally stoop, kneel or crouch\nUse hands and arms to reach for, grasp and manipulate objects\nAccess manufacturing, packaging, warehouse, and laboratory areas, including gowning and PPE as required\nOccasional travel to other PLD sites as required\n\nBENEFITS:\nPLD is a proud equal opportunity employer offering many corporate benefits, including:\n\nMedical and Dental Benefits\nVision\n401K with employer match\nGroup Life Insurance\nFlex Spending Accounts\nPaid Time Off and Paid Holidays\nTuition Assistance\nCorporate Discount Program\nOpportunities to Flourish Within the Company\n\nThe EEO statement needs to be included in the detailed description... PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.\n\n#HP1 (https://employers.indeed.com/reporting/ads/464f974b0b0f2295?startDate=2024-01-01&endDate=2024-01-18)\n\nEqual Opportunity Employer\nThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.","company":"Pl Developments","rawCompany":"pl developments","city":"Garden Grove","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-27T09:56:12.853Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Operational Excellence Engineer","description":"PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.\n\nSUMMARY:\nThe Operational Excellence Engineer serves as the site's certified Lean Six Sigma Black Belt, leading complex, data-driven improvement projects that deliver measurable gains in yield, throughput, quality, cost, and service across OTC pharmaceutical manufacturing and packaging operations. Operating as a senior individual contributor within Operational Excellence, this role leads cross-functional DMAIC and Lean initiatives, applies advanced statistical analysis to solve chronic and high-impact problems, and builds continuous improvement capability by coaching Green Belts, Yellow Belts, and frontline teams. The role also drives digital and data-enabled improvement, partnering with Technical Services and IT to define requirements, and applying GAMP 5 and FDA Computer Software Assurance principles to ensure systems and analytical tools used in GxP decision-making are appropriately validated. All improvements are executed in a cGMP-compliant manner, with changes to validated processes, systems, equipment, and documentation routed through Change Control and approved by Quality Assurance.\n\nWork Schedule: Monday - Friday\nStarting Salary: $91,000\n\nJOB QUALIFICATIONS:\n\nBachelor’s degree in engineering (Industrial, Chemical, Mechanical, Pharmaceutical), Life Sciences, Statistics, or a related technical discipline required; advanced degree preferred\nCertified Lean Six Sigma Black Belt from a recognized body (ASQ, IASSC, or accredited corporate program) required; Master Black Belt certification or candidacy preferred\nMinimum 5–8 years of progressive experience in manufacturing, engineering, or operational excellence, including at least 3 years leading formal Lean Six Sigma projects\nExperience in OTC pharmaceutical, nutraceutical, food, or other FDA-regulated manufacturing strongly preferred; familiarity with solid dose, liquids, creams/ointments, or packaging operations preferred\nStrong working knowledge of FDA regulations and cGMP guidelines, including 21 CFR Parts 210/211 and OTC monograph requirements\nDemonstrated mastery of DMAIC, Lean tools (VSM, 5S, SMED, TPM, standard work, kanban, kaizen), and change management methodology\nAdvanced proficiency in statistical analysis and software such as Minitab, JMP, or equivalent; capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and SPC\nWorking knowledge of OEE, capacity modeling, line balancing, and process cycle efficiency\nWorking knowledge of change control, deviation/CAPA, validation, and risk assessment processes as they apply to process improvement\nExperience extracting and analyzing data from ERP, MES, LIMS, and historian systems; proficiency with Excel and data visualization tools such as Power BI or Tableau preferred\nWorking knowledge of computer system validation principles, including ISPE GAMP 5 software categorization, FDA Computer Software Assurance (CSA) risk-based methodology, 21 CFR Part 11, and ALCOA+ data integrity expectations\nExperience defining user requirements, executing IQ/OQ/PQ or UAT test scripts, and supporting validation deliverables for systems or digital tools supporting manufacturing operations\nFamiliarity with electronic batch records, automated data capture, and digital manufacturing/Industry 4.0 concepts preferred\nProven ability to lead cross-functional teams without direct authority, influence at all organizational levels, and manage multiple concurrent projects\nExcellent written and verbal communication, facilitation, and executive presentation skills\nStrong financial acumen, including the ability to build and validate benefit cases with Finance\n\nPOSITION RESPONSIBILITIES:\n\nProject Leadership & Execution\n\nLead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefits\nApply the DMAIC methodology rigorously: define problem and scope, validate measurement systems, analyze root cause with statistical evidence, pilot and implement solutions, and establish sustainable controls\nPartner with site and functional leadership to identify, scope, prioritize, and charter improvement opportunities aligned to business objectives\nManage project scope, timeline, resources, and risks; escalate barriers and report status to the Vice President, Operational Excellence and site leadership\nQuantify and validate project benefits with Finance, tracking hard savings, cost avoidance, and capacity gains through realization\n\nAnalytics & Problem Solving\n\nPerform advanced statistical analysis including capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and control charting to drive fact-based decisions\nDesign and deploy statistical process control for critical process parameters and quality attributes, establishing limits, monitoring plans, and reaction rules\nLead structured root cause investigations for chronic yield loss, downtime, rework, scrap, right-first-time failures, and repeat deviations\nBuild and maintain operational dashboards and metrics — OEE, throughput, yield, RFT, changeover time, cost per unit — to expose performance gaps and improvement opportunities\n\nLean Deployment & Operating System\n\nFacilitate value stream mapping, kaizen events, and rapid improvement workshops across manufacturing, packaging, warehouse, and laboratory value streams\nDeploy Lean tools including 5S, standard work, SMED/changeover reduction, TPM, visual management, and material flow optimization\nSupport development and sustainment of the site's daily management system, tiered accountability meetings, and problem-solving routines\nDrive waste elimination and cycle time reduction while protecting product quality, compliance, and patient safety\n\nComputer Systems, Data & Digital Improvement\n\nIdentify, scope, and lead improvement projects that leverage computer systems and digital tools to eliminate manual processes, reduce transcription error, and improve data availability across operations\nServe as business process owner or requirements author for system enhancements, configuration changes, reports, and dashboards supporting Operational Excellence, partnering with Technical Services and IT for technical delivery\nDefine user and functional requirements, build traceability to process needs, and participate in design reviews for system changes affecting operational processes\nApply a GAMP 5 and FDA CSA risk-based approach to determine the appropriate validation rigor for system changes, distinguishing between high-risk GxP functionality requiring scripted testing and low-risk functionality suitable for unscripted or exploratory testing\nAuthor and execute test cases including user acceptance testing, and support IQ/OQ/PQ execution for systems and digital tools introduced through improvement projects, submitting deliverables for independent Quality review and approval\nEnsure data integrity and ALCOA+ principles are designed into improved processes, including audit trail adequacy, electronic signature use, user access controls, and record retention\nValidate spreadsheets, statistical models, and analytical tools used for GxP decision-making in accordance with site procedures and GAMP 5 Category classification\nAssess the validation and data integrity impact of process changes on interfaced systems such as ERP, MES, LIMS, historian, and quality systems\nPartner with Technical Services on periodic review, change control, and system lifecycle activities where operational process changes are involved\n\nQuality & Regulatory Compliance\n\nEnsure all improvements affecting validated processes, equipment, utilities, materials, or documentation are executed through Change Control with Quality Assurance review and approval\nAssess regulatory, validation, and product quality impact of proposed changes in partnership with Quality, Regulatory Affairs, and Technical Services\nSupport deviation investigations and CAPA effectiveness through structured problem-solving methodology and statistical evidence\nAuthor and revise SOPs, batch record steps, and work instructions resulting from improvement initiatives, routing through the document control process\nSupport regulatory inspections and customer audits by providing process data, trending, and improvement documentation as requested\n\nCapability Building & Coaching\n\nTrain, coach, and mentor Green Belts, Yellow Belts, supervisors, and frontline teams in Lean Six Sigma tools and structured problem solving\nServe as project sponsor or technical advisor for Green Belt projects, reviewing methodology rigor and validating results\nDevelop and deliver training curriculum supporting the enterprise skills matrix and career pathing framework\nChampion a continuous improvement culture by recognizing contributions, sharing best practices, and standardizing successful solutions across PLD plants\n\nCross-Plant Standardization\n\nReplicate proven improvements across sites to build consistency in process, standard work, and performance expectations\nParticipate in enterprise Operational Excellence forums to share learnings and align on common methodology, metrics, and definitions\n\nPHYSICAL REQUIREMENTS:\n\nOccasionally lift objects weighing up to 25 pounds\nClimb stairs when needed\nStand and walk on the manufacturing floor for extended periods during observations, kaizen events, and time studies\nSit for long periods of time\nOccasionally stoop, kneel or crouch\nUse hands and arms to reach for, grasp and manipulate objects\nAccess manufacturing, packaging, warehouse, and laboratory areas, including gowning and PPE as required\nOccasional travel to other PLD sites as required\n\nBENEFITS:\nPLD is a proud equal opportunity employer offering many corporate benefits, including:\n\nMedical and Dental Benefits\nVision\n401K with employer match\nGroup Life Insurance\nFlex Spending Accounts\nPaid Time Off and Paid Holidays\nTuition Assistance\nCorporate Discount Program\nOpportunities to Flourish Within the Company\n\nThe EEO statement needs to be included in the detailed description... PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.\n\n#HP1 (https://employers.indeed.com/reporting/ads/464f974b0b0f2295?startDate=2024-01-01&endDate=2024-01-18)\n\nEqual Opportunity Employer\nThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.","datePosted":"2026-08-27T09:56:12.853Z","dateModified":"2026-08-27T09:56:12.853Z","hiringOrganization":{"@type":"Organization","name":"Pl Developments","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Garden Grove","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b93e51963e9562a975b97d6a"},"url":"https://jobsearcher.com/jobs/b93e51963e9562a975b97d6a"}}